The anti-epileptic APTIOM, developed by Portuguese pharmaceutical BIAL, will be available for US patients in 2014.
Marketed in Europe since 2009, under the brand ZEBINIX, the drug is the result of 15 years of research and an investment of 300 million euros.
“After Europe, it is with great pleasure that we now see our work recognized, fifteen years of research, by the US regulatory authorities, whose exacting standards such as EMA (European Medicines Agency), are extraordinarily high,” said António Portela, CEO of BIAL group, in a statement to the press.
This is the first time a Portuguese developed pharmaceutical patent is approved by US Food and Drug Administration (FDA) for commercialization in the United States.
“We are especially proud because it is also the first time that the Portuguese pharmaceutical industry has an innovative drug approved in the US,” said Portela.
Based in Marlborough, Massachusetts, Sunovion Pharmaceuticals Inc., BIAL’s trading partner since 2007, will market the drug in the second quarter (April – June) of 2014.
According to figures from the World Health Organization, epilepsy is a neurological disease which affects 50 million people worldwide, 2.2 million in the US.
BIAL is already marketed in 16 European countries (apart from Portugal), 11 countries in Latin America, 20 countries in Africa and in Hong Kong and Macau in China.